Surgical clip with a self-releasing fluid reservoir

ABSTRACT

The present invention generally relates to surgical clips. A surgical clip comprises a first piece comprising a first base and a first projection extending from the first base, a second piece comprising a second base, a second projection extending from the second base wherein the second projection further comprises a top surface, at least one side surface and a bottom surface, the surfaces defining a reservoir therein, and the first and the second piece are detachably connectable. In a preferred embodiment, the reservoir is self-releasing to deliver therapeutic materials when the first piece and second piece are connected.

FIELD OF THE INVENTION

The present invention generally relates to surgical clips used to securetissue together. More specifically, the present invention relates tosurgical clips with a self-releasing reservoir to deliver therapeuticmaterials.

BACKGROUND OF THE INVENTION

The present invention relates to clips for surgical procedures. Surgicalclips are routinely used to secure tissue together during or after manydiffering surgical procedures. In most instances, a surgical procedurewill result in at least one incision that requires closing. In addition,damaged or broken blood vessels, ligaments, bone, tendons, skin andother tissues may also require a means for securing. Surgical clips,preferably, are used to perform the function of securing these and othertissues together.

Surgical clips are known in the prior art and are available in a widevariety of shapes and styles. Generally, the clips comprise one or twopieces. In the case of one-piece clips, the clip will typically fold andlock onto itself while holding tissue in the fold. Similarly, two-piececlips typically secure tissue by holding tissue between the clips whenthey are brought together. In addition to clips, other devices are knownin the prior art that are used to secure tissue together. These devicesinclude clamps, staples, sutures, etc.

Surgical clips generally secure tissue together in the hope that thetissue will then fuse together over a period. In order to facilitatethis process, it is often necessary to administer a therapeutic agent toassist with the repair of the tissue. The therapeutic agent may includesclerosing agents or pharmacological drugs.

Sclerosing agents are believed to irritate tissue, which in turnencourages the tissue to heal. Using a surgical clip in conjunction witha sclerosing agent may facilitate healing. Presently, a therapeuticagent needs to be delivered independently of using surgical clips. Forexample, a physician can administer a therapeutic agent to a desiredarea before or after securing tissue together. Surgical clips thatpossess the ability to deliver a sclerosing agent to tissue in need ofbeing secured together could improve these processes and offer enhancedconvenience.

Additionally, it may be necessary to administer a pharmacological agent.In general, it may be desired to administer a drug that can promotehemostasis. These drugs may promote healing by increasing adhesion andactivation of platelets, increasing fibrin formation, or increasingvascular contraction. Typically, a physician may administer apharmacological agent to an area of interest before or after securingtissue together. By combining the ability to secure tissue and todeliver a pharmacological drug, the process of clipping tissue may bemore convenient and the over-all treatment improved.

Further, many modern surgical techniques are designed to be asnon-invasive as possible. For these surgical techniques, specializedequipment is used that minimizes the size of an incision. For example,specialized clips and clipping techniques are required. Specializedclips are known that enable the joining of tissue when accessibility islimited. For example, clips are known that can be inserted into anincision in order to join ends of tissue below an incision. However, thedelivery of a therapeutic agent would still need to take placeindependently of using the clip. The delivery of a therapeutic agentwould, therefore, require additional specialized equipment. A need,therefore, exists for surgical clips sized for specialized medicalprocedures that can deliver therapeutic agents such as a sclerosingagent or pharmacological drug in conjunction with medical procedures.

SUMMARY OF THE INVENTION

The present invention generally relates to surgical clips used to securetissue together. In a preferred embodiment, a surgical clip comprises afirst piece, a second piece, and a self-releasing reservoir disposedwithin at least one of the pieces that is activated during clipping oftissue and allows for the delivery of a therapeutic agent.

According to a preferred embodiment, the first piece comprises a firstbase and a first projection extending from the first base. Preferably,the first base is generally circular. In an exemplary embodiment, thefirst projection extends substantially perpendicular relative to thefirst base and is generally cylindrical in shape. In preferredembodiments, the first projection includes a proximal portion and adistal portion. The proximal portion is preferably generally cylindricalhaving an outside diameter smaller than that of the first base. Thedistal portion of the first projection is preferably conical in shapeand includes a distal end defined by the tip of the conical shape and aproximal end defined by the base of the conical shape. The conicalshaped distal portion is a preferred means for penetrating the tissue tobe clipped and a preferred means for interacting with the second pieceof the surgical clip described below. The base of the conical shapeddistal portion is preferably generally circular and of a diametergreater than the proximal portion of the first projection. As such, thebase of greater diameter provides an edge or radially projecting edgesurface relative to the proximal portion of the first projection,providing a surface which releasably secures the first piece of the clipto the second piece as described in detail below. Preferably, the firstpiece is constructed of bioabsorbable materials.

In a preferred embodiment, the second piece comprises a second base anda second projection extending from the second base. Preferably, thesecond base is generally circular and of greater diameter than thesecond projection. According to a preferred embodiment, the secondprojection extends substantially perpendicular relative to the secondbase. In an exemplary embodiment, the second projection is generallycylindrical in shape. Preferably, the second piece is constructed ofbioabsorbable materials.

In a preferred embodiment, the second projection further comprises a topsurface, at least one side surface and a bottom surface. These surfacesdefine a reservoir. Preferably, the reservoir contains a selected amountof a therapeutic agent, for example a sclerosing agent orpharmacological drug.

According to a preferred embodiment, the first piece and the secondpiece are detachably connectable. Preferably, the first projection andthe second projection are shaped suitably to mate when brought together.In a preferred embodiment, the second projection comprises a means toslidably receive the first projection. In an alternative embodiment, thefirst projection receives the second projection.

In a preferred embodiment, detachably connecting the first piece and thesecond piece allows the release of a therapeutic agent from thereservoir. According to a preferred embodiment, the front surfaceoverlies the hollow reservoir. In an exemplary embodiment, the frontsurface comprises puncturable material so that connecting the firstpiece and the second piece allows at least the distal portion of thefirst projection to pierce the front surface. Piercing the front surfacepreferably releases the therapeutic agent from the reservoir.

In a preferred embodiment, the second projection further comprises atleast one aperture sized to allow the flow of a therapeutic agent out ofthe reservoir. According to a preferred embodiment, when the first pieceand the second piece are detachably connected, a therapeutic agent canflow out from the reservoir through the apertures which are preferablylocated in the side wall between the top and bottom surfaces.

In a preferred embodiment, tissue in need of being secured can besecured together by placing the first piece and the second piece in theproximity of the tissue. Preferably, when the first piece and the secondpiece are detachably connected, they secure the tissue together.Detachably connecting the first piece and the second piece results inthe flow of a therapeutic agent from the reservoir to an area ofinterest proximate a tissue in need of being secured. In an exemplaryembodiment, when the first piece and the second piece are connected, atherapeutic agent is released from at least one aperture containedwithin the second projection.

According to multiple embodiments of the current invention, tissue inneed of being secured together may include, but is not limited to, ablood vessel, a ligament, a bone, a tendon, and skin. In an exemplaryembodiment, the surgical clips can be sized for specialized surgicaltechniques. Preferably, the clips can be small enough to enter anincision in order to join tissue below the incision. A person ofordinary skill in the art would be familiar with determining tissueappropriate for multiple embodiments of the current invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective cross-sectional view depicting a surgical clipaccording to a preferred embodiment of the current invention;

FIG. 2 is a cross-sectional view of the surgical clip of FIG. 1depicting an arrangement appropriate for detachably connecting a firstpiece and a second piece; and

FIG. 3 is a cross-sectional view of the surgical clip of FIG. 2, whereinthe first piece and the second piece are detachably connected and atherapeutic substance is released therefrom.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings wherein like reference numerals indicatelike elements throughout the several views, FIG. 1 depicts a surgicalclip according to a preferred embodiment of the current invention.Preferably, the surgical clip can be used in conjunction with a medicalprocedure to secure tissue together. In an exemplary embodiment, thesurgical clip can be used to secure tissue together and concurrentlydeliver a therapeutic agent.

In a preferred embodiment, surgical clip 10 comprises first piece 12 andsecond piece 14. First piece 12 and second piece 14 are preferablyconstructed of bioabsorbable materials. Bioabsorbable materials caninclude, but are not limited to, poly(L-lactide) (PLLA),poly(D,L-lactide) (PLA), poly(glycolide) (PGA), poly(L-lactide-co-D.L.Lactide) (PLLA/PLA), poly(L-lactide-co-glycolide) (PLA/PGA),poly(glocolide-co-trimethylene carbonate) (PGA/PTMC), polydioxanone(PDS), polycaprolactone (PCL), polyhydroxybutyrate (PHBT),poly(phosphazenes), poly(D,L-lactide-co-caprolactone) (PLA/PCL),poly(glycolide-co-caprolactone) (PGA/PCL), poly(phosphase ester) andpolyanhydrides. A person of ordinary skill in the art would be familiarwith choosing an appropriate material for constructing first piece 12and second piece 14 according to multiple embodiments of the currentinvention. The materials could be selected from any biocompatiblematerial for selected permanent or temporary application.

Preferably, embodiments of the invention include surgical clips sizedfor differing surgical procedures. In one preferred embodiment, surgicalclip 10 can be sized appropriately to enter an incision in order to jointissue below the incision. One of ordinary skill in the art would befamiliar with choosing an appropriate size of surgical clip 10 accordingto a selected use of the current invention.

First piece 12 further comprises first base 16 and first projection 18extending from first base 16. First base 16 is preferably generallycircular. According to a preferred embodiment, first projection 18extends substantially perpendicular from first piece 12 relative tofirst base 16. Further, first base 16 is preferably of larger diameterthan first projection 18 so that in use, first projection 18 is insertedthrough tissue which is to be secured, while first base 16 provides anenlarged planar surface 17 which contacts tissue proximate firstprojection 18 and holds it in place.

Second piece 14 further comprises a second base 20 and a secondprojection 22 extending from the second base 20. In an exemplaryembodiment, second base 20 is generally circular. Preferably, secondprojection 22 is substantially cylindrical in shape. According to apreferred embodiment, second projection 22 extends substantiallyperpendicular from second piece 14 relative to second base 20. As withfirst piece 12, second base 20 is preferably of larger diameter thansecond projection 22 so that in use, second projection 22 is insertedthrough tissue to be secured, while second base 20 provides an enlargedplanar surface 21 which contacts tissue proximate second projection 22and holds it in place.

In a preferred embodiment of the current invention, second projection 22further comprises top surface 24, at least one side surface 26 andbottom surface 30. Bottom surface 30 preferably comprises a portion ofsecond base 20. In an exemplary embodiment, second base 20 is hollow. Ina preferred embodiment, top surface 24, side surface 26 and bottomsurface 30 define reservoir 32 which, as previously stated, ispreferably cylindrical in shape.

First piece 12 and second piece 14 are designed so that in use the twopieces cooperate to form a unitary, preferably releasably securedsurgical clip 10 having enlarged planar surfaces 17 and 21 opposing eachother and holding secured tissue therebetween. As depicted in FIG. 1,structural features have been incorporated into first projection 18 andsecond projection 22 to provide means for securing the first piece 12 tothe second piece 14. Second piece 14 includes second projection 22 whichpreferably is generally cylindrical in shape and having a hollowreservoir 32 therein. The top surface 24 of the second projection 22preferably incorporates a rim portion 31 which includes an opening ofdiameter slightly smaller than the inside diameter of the cylindricalshape defined by the second projection 22. This rim member 31 cooperateswith the first projection 18 of first piece 12 to secure the memberstogether.

To cooperate with the above-described design of second piece 14, thefirst projection 18 preferably includes a proximal portion 19 and adistal portion 15. The proximal portion 19 is preferably generallycylindrical and has an outside diameter smaller than that of the base asdescribed above. The distal portion 15 of the first projection 18 ispreferably generally conical in shape and includes a distal end 13defined by the tip of the conical shape at a proximal end 11 defined bythe base of the conical shape. The conical shaped distal portion is apreferred means for penetrating the tissue to be clipped and a preferredmeans for interacting with the second piece 14 of the surgical clip. Thebase 11 of the conical shaped distal portion 15 is preferably generallycircular and of a diameter greater than the proximal portion 19 of thefirst projection 18. As such, the base 11 of greater diameter providesan edge or radially projecting edge surface relative to the proximalportion 19 of the first projection 18. This surface secures the twopieces of the clip together when this portion passes through the rimportion 31 of the second piece 14. FIG. 3 depicts these pieces securedtogether as described.

Preferably, top surface 24 comprises a puncturable material portion 25filling the opening through rim portion 31. According to a preferredembodiment, connecting first piece 12 and second piece 14, as describedabove results in the puncture of puncturable material portion 25 of topsurface 24. One of ordinary skill in the art would be familiar withpuncturable materials appropriate for selected embodiments of thecurrent invention. Bioabsorbable polymeric films would be especiallysuitable for use.

In a preferred embodiment, second projection 22 further comprises atleast one aperture 23 sized to allow the flow of a therapeutic agent 34out of reservoir 32. According to a preferred embodiment, detachablyconnecting first piece 12 and second piece 14 results in the release ofa therapeutic agent through aperture 23.

In alternative embodiments, first piece 12 and second piece 14 aredetachably connectable utilizing other known designs wherein secondpiece 14 comprises a cross-sectional profile adapted to mate with firstprojection 18 of first piece 12. In each preferred embodiment, firstpiece 12 is adapted to pierce top surface 24 of second projection 22.

Reservoir 32, defined by second projection 22, preferably contains apredetermined amount of a therapeutic agent. The therapeutic agent mayinclude, but is not limited to, a sclerosing agent or a pharmacologicalagent. For example, sclerosing agents may include; but are not limitedto, sodium morrhuate, ethanolamine oleate, sotradecol, polidocanol,scleremo, hypertonic saline, sclerodex, and polyiodinated iodine.

Alternatively, for example, pharmacological agents may include, but arenot limited to, vitamin K (phytomenadione), menadiol sodium diphosphate,warfarin, low-molecular-weight lieparins (LMWHs), heparin, protaminesulfate, dermatan sulfate, and any other drug affecting hemostasis.Numerous pharmacological agents have been set forth in the foregoingdescription. It will be understood, however, that this disclosure is, inmany respects, only illustrative and that multiple other pharmacologicalagents could be used in place of the list above.

FIG. 2 is a cross-sectional view of a surgical clip in an arrangementappropriate for detachably connecting the first piece and second piece.First piece 12 and second piece 14 of surgical clip 10 are detachablyconnectable. First piece 12 comprises first projection 18 extending fromfirst base 16. Second piece 14 comprises second projection 22 extendingfrom second base 20. Second piece 14 further comprises top surface 24,side surface 26, and bottom surface 30 that define reservoir 32. In apreferred embodiment of the current invention, reservoir 32 containstherapeutic agent 34.

Preferably, first projection 18 and second projection 22 are shapedsuitably to mate when brought together. In a preferred embodiment,second projection 22 comprises a means to slidably receive firstprojection 18. In an alternative embodiment, first projection 18slidably receives second projection 22.

In a preferred embodiment, detachably connecting first piece 12 andsecond piece 14 causes the release of therapeutic agent 34 fromreservoir 32. According to a preferred embodiment, top surface 24 ishollow. In an exemplary embodiment, top surface 24 comprises puncturablematerial 25 over the opening in rim portion 31 so that connecting firstpiece 12 and second piece 14 allows first projection 18 to pierce topsurface 24. Piercing top surface 24 preferably begins release oftherapeutic agent 34 from reservoir 32 through apertures 23.

FIG. 3 depicts the surgical clip of FIG. 2, wherein the first piece andsecond piece are detachably connected.

Second piece 14 is depicted with a cross-sectional profile that is matedwith first projection 18 of first piece 12. First piece 12 has piercedthe top surface 24 of second projection 22. Planar surfaces 17 and 21oppose each other to secure tissue 36 together. First projection 18 andsecond projection 22 pass through the tissue 36. As shown, therapeuticagent 34 has been released from reservoir 32 of second projection 22through the at least one aperture 23.

According to multiple embodiments of the current invention, tissue 36 inneed of being secured together may include, but is not limited to, ablood vessel, a ligament, a bone, a tendon, and skin. A person ofordinary skill in the art would be familiar with determining tissueappropriate for multiple embodiments of the current invention.

Numerous advantages of the invention covered by this document have beenset forth in the foregoing description. It will be understood, however,that this disclosure is, in many respects, only illustrative. Changesmay be made in details, particularly in matters of shape, size, andarrangement of steps without exceeding the scope of the invention. Theinvention's scope is, of course, defined in the language in which theappended claims are expressed.

1-21. (canceled)
 22. A surgical fastener for fastening tissue segmentshaving tissue surfaces, the fastener comprising: a first fastenermember; a second fastener member configured to receive and retain thefirst fastener member and implantable within the body such that thetissue segments to be fastened are retained between the first and secondfastener members and such that bodily fluid flow through the fastenermembers is substantially prevented; and means for promoting adhesionbetween the tissue surfaces.
 23. The fastener according to claim 22,wherein the first fastener member comprises a base and a piercingelement connected to the base for piercing the tissue segments to befastened.
 24. The fastener according to claim 23, wherein the secondfastener member comprises an opening to receive and retain the piercingelement of the first fastener member.
 25. The fastener according toclaim 22 wherein the means for promoting adhesion comprises atherapeutic agent contained in the second fastener member.
 26. Thefastener according to claim 25, wherein the second fastener memberdefines a passageway that allows delivery of the therapeutic agent fromthe second fastener member to the tissue segments.
 27. The fasteneraccording to claim 25, wherein the therapeutic agent comprises at leastone of a sclerosing agent and a pharmacological agent.
 28. The fasteneraccording to claim 25, wherein the second fastener member has a base anda hollow projection extending from the base, the base and the hollowprojection defining a reservoir for containing the therapeutic agent.29. The fastener according to claim 28, wherein the hollow projectioncomprises an aperture extending in a direction transverse to alongitudinal axis of the projection, the aperture defining a passagewayfor allowing delivery of the therapeutic agent from the reservoir to thetissue segments.
 30. The fastener according to claim 28, wherein thereservoir is covered with a puncturable material, wherein engagementbetween the first and second fastener members causes the first fastenermember to pierce the puncturable material, thereby allowing delivery ofthe therapeutic agent from the reservoir to the tissue segments.
 31. Thefastener according to claim 28, wherein the hollow projection isconfigured to receive and retain the first fastener member.
 32. Asurgical fastener for fastening tissue segments having tissue surfaces,the fastener comprising: a first fastener member; and a second fastenermember having a post defining an opening for receiving and retaining thefirst fastener member such that the tissue segments to be fastened areretained between the first and second fastener members and such thatbodily fluid flow through the fastener members is substantiallyprevented.
 33. The fastener according to claim 32, wherein the firstfastener member has a base and a piercing element connected to the basefor piercing the tissue segments to be fastened, and the opening isconfigured to receive and retain the piercing element.
 34. The fasteneraccording to claim 32, further comprising a reservoir containing atherapeutic agent.
 35. The fastener according to claim 34, wherein thetherapeutic agent comprises at least one of a sclerosing agent and apharmacological agent.
 36. The fastener according to claim 34, whereinthe reservoir is located proximate the opening of the post.
 37. Thefastener according to claim 34, wherein the reservoir is located insidethe post.
 38. The fastener according to claim 34, wherein the secondfastener member defines a passageway that allows delivery of thetherapeutic agent from the reservoir to the tissue segments.
 39. Thefastener according to claim 34, wherein the post comprises an apertureextending in a direction transverse to a longitudinal axis of the post,the aperture defining a passageway for allowing delivery of thetherapeutic agent from the reservoir to the tissue segments.
 40. Thefastener according to claim 34, wherein the reservoir is covered with apuncturable material, wherein engagement between the first and secondfastener members causes the first fastener member to pierce thepuncturable material, thereby allowing delivery of the therapeutic agentfrom the reservoir to the tissue segments.
 41. A method of fasteningsurfaces of tissue segments, the method comprising: piercing the tissuesegments to be fastened with a tissue fastener; retaining the tissuesegments to be fastened between parts of the tissue fastener; anddelivering a therapeutic agent to the interface between the surfaces ofthe tissue segments to be joined, wherein the tissue segments arefastened so as to substantially prevent bodily fluid flow through theparts of the tissue fastener.
 42. The method of claim 41, wherein thetherapeutic agent comprises at least one of a sclerosing agent and apharmacological agent.
 43. The method of claim 41, wherein parts of thetissue fastener include a first part and a second part, piercing thetissue segments includes piercing the tissue segments with the firstpart, and retaining the tissue segments includes receiving the firstpart in the second part.
 44. The method of claim 43, wherein thetherapeutic agent is contained in the second part, and delivering thetherapeutic agent comprises delivering the therapeutic agent from thesecond part to the tissue segments.
 45. The method of claim 44, whereinengaging the first and second parts of the tissue fastener causes thetherapeutic agent to be delivered to the tissue segments.
 46. The methodof claim 45, wherein the second part defines a passageway that allowsdelivery of the therapeutic agent from the second part to the tissuesegments.
 47. The method of claim 41, wherein the second part comprisesa reservoir for containing the therapeutic agent.